FLUOROURACIL CREAM, 0.5% and OFF LABEL USE

Overview

OFF LABEL USE is the #5 most commonly reported adverse reaction for FLUOROURACIL CREAM, 0.5%, manufactured by Dr. Reddy's Laboratories Inc.. There are 3,277 FDA adverse event reports linking FLUOROURACIL CREAM, 0.5% to OFF LABEL USE. This represents approximately 2.7% of all 122,970 adverse event reports for this drug.

Patients taking FLUOROURACIL CREAM, 0.5% who experience off label use should discuss this symptom with their healthcare provider to determine whether it may be related to their medication and what alternatives may be available.

Reporting Frequency

OFF LABEL USE3,277 of 122,970 reports

OFF LABEL USE is a less commonly reported adverse event for FLUOROURACIL CREAM, 0.5%, but still significant enough to appear in the safety profile.

Other Side Effects of FLUOROURACIL CREAM, 0.5%

In addition to off label use, the following adverse reactions have been reported for FLUOROURACIL CREAM, 0.5%:

DIARRHOEA — 6,625 reports
NEUTROPENIA — 4,984 reports
NAUSEA — 4,689 reports
VOMITING — 3,786 reports
DISEASE PROGRESSION — 3,136 reports
NEUROPATHY PERIPHERAL — 3,104 reports
PYREXIA — 2,927 reports
FATIGUE — 2,899 reports
THROMBOCYTOPENIA — 2,845 reports
FEBRILE NEUTROPENIA — 2,780 reports

Other Drugs Associated with OFF LABEL USE

The following drugs have also been linked to off label use in FDA adverse event reports:

0XYGEN ABACAVIR SULFATE ABATACEPT ABIRATERONE ACETATE ACALABRUTINIB ACETAMINOPHEN ACETAMINOPHEN 500MG ACETAMINOPHEN AND CODEINE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, ASPIRIN, AND CAFFEINE ACETAMINOPHEN, ASPIRIN, CAFFEINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE ACETAMINOPHEN, CAFFEINE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, IBUPROFEN

Does FLUOROURACIL CREAM, 0.5% cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 3,277 FDA reports for FLUOROURACIL CREAM, 0.5%. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with FLUOROURACIL CREAM, 0.5%?

OFF LABEL USE accounts for approximately 2.7% of all adverse event reports for FLUOROURACIL CREAM, 0.5%, making it a notable side effect.

What should I do if I experience OFF LABEL USE while taking FLUOROURACIL CREAM, 0.5%?

If you experience off label use while taking FLUOROURACIL CREAM, 0.5%, contact your healthcare provider. They can evaluate whether the symptom is related to your medication and discuss potential adjustments to your treatment plan. Do not stop taking prescribed medication without consulting your doctor.